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Clinical Trials/NCT02320240
NCT02320240
Completed
Not Applicable

Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury

Canadian Network for Observational Drug Effect Studies, CNODES1 site in 1 country3,255,526 target enrollmentJune 2013

Overview

Phase
Not Applicable
Intervention
Duloxetine
Conditions
Depression
Sponsor
Canadian Network for Observational Drug Effect Studies, CNODES
Enrollment
3255526
Locations
1
Primary Endpoint
Acute Kidney Injury (AKI)
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The purpose of this study is to determine if there is an excess risk of acute kidney injury (AKI) with Serotonin-norepinephrine reuptake inhibitors (SNRIs) as compared to Selective serotonin reuptake inhibitors (SSRIs), two classes of medication used for the treatment of depression.

Detailed Description

We plan to conduct retrospective population-based cohort studies within eight administrative databases from Canada, the United States, and the United Kingdom. Within each cohort, a nested case-control analysis will be performed to estimate incidence rate ratios (RR) of AKI associated with SNRIs compared to SSRIs using conditional logistic regression, with adjustment for high-dimensional propensity scores at baseline. The overall effect across sites will then be estimated using meta-analytic methods.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
December 2014
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Canadian Network for Observational Drug Effect Studies, CNODES
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • A first prescription of an antidepressant of the SNRI or SSRI class of any dose between January 1, 1997 and March 31, 2010.

Exclusion Criteria

  • They were \<12 years old at the time of cohort entry.
  • They had less than 1 year of information in the database prior to the date of cohort entry.
  • They had a prescription of an SNRI or SSRI in the year before the date of cohort entry.
  • They had a prescription for both an SNRI and an SSRI on the day of cohort entry.
  • They had a history of chronic kidney disease (including kidney transplantation and dialysis) or AKI in the year preceding cohort entry.
  • The subject was previously included in the cohort.

Arms & Interventions

SNRI Exposure Group

Patients who received a new prescription for an SNRI (duloxetine, venlafaxine, or desvenlafaxine at any dosage) with no prescriptions for either SNRI or SSRI in the prior year.

Intervention: Duloxetine

SNRI Exposure Group

Patients who received a new prescription for an SNRI (duloxetine, venlafaxine, or desvenlafaxine at any dosage) with no prescriptions for either SNRI or SSRI in the prior year.

Intervention: Venlafaxine

SNRI Exposure Group

Patients who received a new prescription for an SNRI (duloxetine, venlafaxine, or desvenlafaxine at any dosage) with no prescriptions for either SNRI or SSRI in the prior year.

Intervention: Desvenlafaxine

SSRI Exposure Group

Patients who received a new prescription for an SSRI (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline at any dosage) with no prescriptions for either SSRI or SNRI in the prior year.

Intervention: Citalopram

SSRI Exposure Group

Patients who received a new prescription for an SSRI (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline at any dosage) with no prescriptions for either SSRI or SNRI in the prior year.

Intervention: Escitalopram

SSRI Exposure Group

Patients who received a new prescription for an SSRI (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline at any dosage) with no prescriptions for either SSRI or SNRI in the prior year.

Intervention: Fluoxetine

SSRI Exposure Group

Patients who received a new prescription for an SSRI (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline at any dosage) with no prescriptions for either SSRI or SNRI in the prior year.

Intervention: Fluvoxamine

SSRI Exposure Group

Patients who received a new prescription for an SSRI (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline at any dosage) with no prescriptions for either SSRI or SNRI in the prior year.

Intervention: Paroxetine

SSRI Exposure Group

Patients who received a new prescription for an SSRI (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline at any dosage) with no prescriptions for either SSRI or SNRI in the prior year.

Intervention: Sertraline

Outcomes

Primary Outcomes

Acute Kidney Injury (AKI)

Time Frame: 2 years

AKI will be defined as patients hospitalized with one of the following diagnosis codes for AKI in any of the listed diagnoses: ICD-9-CM codes 584, 584.5, 584.6, 584.7, 584.8, or 584.9; ICD-10 N17, N17.0, N17.1, N17.2, N17.8, or N17.9.

Study Sites (1)

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